Clinical Trial

Injection Versus Suture Repair of Laryngeal Clefts

Enrolling by Invitation
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Summary
The purpose of the study is to learn more about a procedure that may be helpful for the participant's swallowing issues. The investigators are hoping to find out if one type of procedure is the same or better than another type of procedure at improving participant's issues with swallowing. Participants will get one of two procedures. One is called injection laryngoplasty (IL) and injects a gel into the back wall of the participant's airway to prevent food and liquid from falling in. The other procedure is called endoscopic suture repair (ER) and uses sutures to sew together and build up the back wall of the participant's airway to prevent food and liquid from falling in. Participants will be asked to have a number of tests and procedures. These include a modified barium swallow study, in which the participant drinks and eats foods and liquids with barium in them and X-rays are used to assess how the food moves through the participant's body. This will be done before the procedure and 3 months after the procedure. The investigators will also give participants questionnaires to complete before and after the procedure.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-06-30.
Status change: Not Yet Recruiting → Enrolling by Invitation 2025-09-23
Trial Details
NCT Number NCT07057258
Lead Sponsor Oregon Health and Science University
Conditions Laryngeal Cleft, Dysphagia
Enrollment 128 participants
Start Date 2025-09-01
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-29